The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 11 No. 7 • December 2008


Public Comments

GlaxoSmithKline and Allies
Petition the FDA to Disallow
Weight Loss Claims for Dietary Supplements

They never give up—the drug companies that is—trying to get the FDA to eliminate competitive products when consumers don’t buy “enough” of their own voluntarily. In this case, GlaxoSmithKline is the manufacturer of a weight loss drug, Alli®, an over-the-counter nonprescription version of the drug orlistat (Xenical®). Apparently, they are not happy with its sales. A recent Citizen Petition filed by GlaxoSmithKline (joined by the American Dietetic Association, the Obesity Society, and Shaping America’s Health (a sister organization of the ADA)) asks the FDA to ban weight loss claims for dietary supplements, arguing that they are (in effect) drug claims because they claim to treat excess weight which, the petitioners say, is a risk factor for many diseases. They point out that FDA doesn’t permit a dietary supplement health claim for cholesterol reduction because that might be understood as a claim to reduce heart disease risk. (Note that, under GlaxoSmithKline et al’s interpretation, one couldn’t even claim that a high fiber diet, reduced calorie intake, or a low glycemic index diet, let alone a food studied extensively for its weight loss effects, green tea, could help people lose weight.) The Petition also claims that there is no evidence that dietary supplements can cause weight loss! We filed vehement objections with the FDA in opposition to the Petition (see end of this newsletter).

If it isn’t auto companies trying to get immense amounts of taxpayers’ money now (and with the certainty of “needing” more again and again later) to support a losing business model, it is drug companies seeking to use the guns of the FDA to drive competition from the market. (To be fair, the auto companies’ “losing business model” is partly the result of federal mandates requiring that the companies build and attempt to sell small, fuel-thrifty vehicles as a large proportion of their product line, where they lose money on each sale. Another big part of the “loser business model” is acquiescence to labor demands for huge pensions and health-care benefits, pay for not working when laid off, and far higher average wages than those paid at non-unionized American auto manufacturers, such as Toyota.

The purpose of the proposed auto company bailouts is to subsidize the losing business model and to allow the federal government to add additional politically-correct federal mandates that would make it an even bigger loser; hence, large amounts of “government” money would need to be periodically injected forever (from taxes and borrowing as well as inflating the money supply). Just as Medicare is Amtrak medicine, the new GM, Ford, and Chrysler would be Amtrak Goes Wild.

I hope your committee will not permit doubts as to constitutionality, however reasonable, to block the suggested legislation.
— Franklin Delano Roosevelt: Letter to the Ways and Means Committee of the House of Representatives (on the Guffey-Snyder Coal Bill), July, 1935
The United States Constitution has proved itself the most marvelously elastic compilation of rules of government ever written.
— F.D.R., Radio speech, Mar. 2, 1930

October ___, 2008
Division of Dockets Management
Food and Drug Administration
Department of Health and Human Services
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Re: Comment in Response to Citizen Petition Requesting FDA to Treat Weight Loss Claims for Dietary Supplements as Disease Claims, filed April 17, 2008

Durk Pearson and Sandy Shaw, by counsel, hereby submit comments in response to the Citizen Petition of GlaxoSmithKline and each of the proxies that it financially backs, the American Dietetic Association; the Obesity Society; and Shaping America’s Health, who it identifies as co-petitioners.

At the outset, GlaxoSmithKline has violated the agency’s citizen petition rule, 21 CFR § 10.30, because it has not identified a conflict of interest. GlaxoSmithKline sells the over-the-counter weight loss drug Alli. Alli competes for market share with all manner of weight loss remedies, including those that come in the form of dietary supplements and those that come in the form of modified, low caloric foods, low calorie density high fiber foods, and low glycemic index foods, some of which are often sold as part of a meal plan. The problem with Alli is that it causes anal leakage, an urgent need to void, and depletes fat soluble essential nutrient stores, thus increasing the risk of nutrient deficiency related diseases such as osteoporosis; heart disease; and cancer. Those aspects as well as its limited efficacy and possibly its price have kept the product from achieving market success despite heavy promotion by GlaxoSmithKline.

In a transparent attempt to induce FDA to assist in an anti-competitive campaign to eliminate its competitors, GlaxoSmithKline now asks FDA to declare claims heretofore permitted for dietary supplements that affect weight loss (and presumably also for modified dietetic foods that affect weight loss) unlawful. GlaxoSmithKline seeks a blanket speech ban, imposing a prior restraint upon all existing and future nutrient based claims that would inform consumers of weight loss effects and potential of those products.

Ironically, GlaxoSmithKline is unwittingly inviting a boomerang effect. If, indeed, it is correct that weight is inextricably a symptom of serious disease, including type two diabetes, heart disease, cancer, metabolic syndrome, etc., which are states that require medical intervention and management, then its product Alli needs to be removed from the market. That is because Alli purports to reduce weight which, according to GlaxoSmithKline logic, is inextricably linked to serious disease; ergo, Alli should only be available by prescription; hence, off the over-the-counter market it must go lest serious disease states go undetected or, worse yet, become subject to the mistaken belief that they are self-treatable through ingestion of Alli.

GlaxoSmithKline asks the FDA to adopt a blanket speech ban. It does so based on the following syllogism which contains false representations of fact and non-sequiturs. GlaxoSmithKline argues: (1) that overweight is a contributing factor to serious disease, including diabetes, heart disease, cancer, and metabolic syndrome, among others; (2) that, thus, weight is a classic sign or symptom of disease making it ineligible for use in structure/function claims for dietary supplements (and presumably foods); (3) that no dietary supplement affects weight loss, thus making claims to that effect inherently false and misleading; and (4) that FDA may act unilaterally, without rulemaking, to reclassify all claims concerning the weight loss effects of dietary supplements (and presumably foods) as drug claims condemnable for supplements (and presumably foods) but allowable for drugs, including (and most especially) for GlaxoSmithKline’s Alli.

Factual and legal problems plague this syllogism and invite ready challenge if the FDA proves so bold that it harkens GlaxoSmithKline’s anticompetitive call with action to eliminate all weight loss claims from the supplement (and presumably the food) marketplaces to the great detriment of consumers and the sure violation of the First Amendment. Let us first consider the factual problems.

GlaxoSmithKline’s False Facts

Overweight Is Not Per Se a Sign or Symptom of Disease. GlaxoSmithKline relies on the BMI index as a standard for determining overweight status and deems overweight status per se a sign or symptom of disease. The supposition is false. Chronic overweight status at a level of ten or more pounds above the BMI may contribute to a diverse array of disease conditions but has not been shown to be a causative factor for initiation or progression of any single disease cited by GlaxoSmithKline. Overweight status that is transient or that is below a level of ten pounds above the BMI is not linked to disease of any kind. See ______________. Based on this logic, the FDA drew a distinction in its Final Rule on structure/function claims recognizing that overweight status, as opposed to obesity, is a normative condition, while the latter is a disease condition. That solves the problem nicely because while obesity (defined as a BMI of 30 or more) is itself a disease and may contribute to a host of diseases mentioned by GlaxoSmithKline; overweight status is too generalized a condition to be categorized as either a disease in and of itself or a causative factor contributing to disease. Furthermore, BMI does not distinguish between high percentages of body fat (unhealthy) and muscle (healthy). Many Olympic athletes have BMIs in the “overweight” to “obese” range.

Moreover, each disease state cited by GlaxoSmithKline is one for which there are multiple known causative factors and while overweight may contribute, it has not been shown to be the causative factor for the diseases in question. That makes overweight status an inadequate distinguishing principle, because it may also be said that aging may be a contributing factor to those same disease states, as may excess consumption of sugar, as may ingestion of excess alcohol, as may consumption of excess saturated fats in lunch meats, as may consumption of excess high fructose corn syrup in beverages. GlaxoSmithKline thus proceeds down a slippery slope that if not checked results in a wholesale transformation of the speech marketplace where almost all structure/function claims become presumptively unlawful as drug claims on the weak reed that they concern physiological processes that may under certain conditions contribute ultimately to the manifestation of disease states. This would result in a ban on all structure-function claims because all physiological processes can be, under certain conditions, part of a disease process. FDA should guard against that move because it entails direct and substantial censorship of truthful information concerning the effect of nutrients on health related conditions and will be to the grave detriment of consumers of foods and nutrients.

Even obesity is not always a sign or symptom of disease. A new paper reports that a 1999–2004 database of 5440 participants aged 20 years or older in the National Health and Nutrition Examination Survey (NHANES) that (as determined by measuring a selected set of physiological functions) approximately 29% of obese men (BMI over 30.0) and approximately 35% of obese women (BMI over 30.0) were metabolically normal. This paper also reports that approximately 30% of normal weight men (BMI less than 25.0) and approximately 21% of normal weight women (BMI less than 25.0) were metabolically abnormal. Hence, BMI alone is not a reliable indicator of whether there is disease present and, hence, overweight or even obesity cannot be, as claimed by Glaxo et al’s Citizen Petition, a per se sign or symptom of disease. See Wildman et al, “The obese without cardiometabolic risk factor clustering and the normal weight with cardiometabolic risk factor clustering: prevelance and correlates of 2 phenotypes among the US population NHANES 1999–2004,” Arch. Intern. Med. 168:1617–1624 (2008)

Dietary Ingredients And Supplements Do Affect Weight. GlaxoSmithKline makes the cavalier statement that no dietary supplement affects weight. It relies on a myopic and selective excerpting of the scientific literature to support that proposition and upon a panel having economic interests tied to GlaxoSmithKline for support. The peer-reviewed scientific evidence reveals dietary ingredients and supplements that do affect weight status. Those include green tea and black tea (which increase energy expenditure and reduce food intake); caffeine (which increases energy expenditure and reduces food intake); capsaicin (which increases energy expenditure and is synergistic with caffeine); mustard (which increases energy expenditure); high protein-low fat diets; and high fiber diets. See Exhibit A hereto (over 60 peer reviewed scientific journal articles concerning the weight loss effects of the foregoing).

Note well that FDA possesses the statutory authority to prosecute any who make false and misleading claims and has acted under that authority to address false weight loss claims for supplements. 31 U.S.C. § 342(f)(1)(A); See Hi-Tech Pharms., Inc. v. Crawford, F. Supp. 2d 1341 (N.D. GA 2007). That selective enforcement avoids the constitutional violations, described below, inherent in the blanket ban GlaxoSmithKline seeks. It achieves the objective of ensuring that consumers have available to them an entire array of truthful information concerning the effects of nutrients on weight status without restricting that information for the exclusive use of pharmaceutical companies holding FDA approved weight loss drugs.

GlaxoSmithKline’s Call for Unconstitutional Agency Action

GlaxoSmithKline asks FDA to declare all weight loss claims for dietary supplements forbidden. That blanket speech ban is presumptively unconstitutional under the First Amendment commercial speech standard. See Edenfield v. Fane, 507 U.S. 761, 769 (1993).

Moreover, the blanket ban is particularly problematic because it presumes all speech concerning weight loss effects of dietary supplements to be false. Two problems arise. First, undoubtedly some claims are true, dependent upon their wording, and second, there are obvious less speech restrictive alternatives to outright suppression: case by case enforcement and reliance on disclaimers as a less speech restrictive alternative when disclaimers can cure deceptiveness.

So, e.g., a claim that mirrors the state and substance of scientific evidence concerning any one dietary ingredient’s effect on weight would be true. If, for example, the scientific evidence revealed that a dietary substance, e.g., common tea or fiber, reduced desire to consume by creating a feeling of satiety, a carefully crafted representation of the evidence without a specific recitation of unprovable quantums of weight loss achievable would not be inherently misleading. Thus, suppression of the claim based on the notion that a penultimate relationship between ingestion of the substance and pounds lost had not been shown would be unconstitutional, as the Pearson v. Shalala case so amply confirms. Pearson v. Shalala, 164 F.3d 650, 655 (D.C. Cir. 1999); Whitaker v. Thompson, 284 F.Supp.2d 13, 15 (D.D.C. 2002). See also Thompson v. W.States Med. Ctr., 535 U.S. 357 (2002).

Under the four part Central Hudson test it is thus the case that the FDA could not determine presently, without a specific claim before it, that all weight loss claims for a dietary supplement would be false. Each claim’s validity depends on its precise wording and the evolving scientific evidence upon which the claim is based. Consequently, a blanket ban will necessarily result in suppression of non-misleading claims thus making it presumptively unconstitutional. See Thompson v. Western States Med. Ctr., 535 U.S. 357, 377 (2002) (speech ban that presumptively precludes non-misleading speech along with that which is inherently misleading does not survive constitutional scrutiny under the commercial speech test); (44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 502 (1996) (“complete speech bans . . . are particularly dangerous because they foreclose alternative means of disseminating certain information”); Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626, 636 (1985) (“The State’s burden is not slight; the free flow of commercial information is valuable enough to justify imposing on would-be regulators the costs of distinguishing the truthful from the false, the helpful from the misleading, the harmless from the harmful”); Ibanez v. Fla. Dep’t of Bus. & Prof’l Regulation, 512 U.S. 136 (1994) (speech ban that encompasses non-misleading statement did not withstand constitutional scrutiny because government unable to establish that ban directly and materially advances substantial state interest); see also Pearson v. Shalala,164 F.3d 650, 655 (D.C. Cir. 1999) (Government may impose a blanket ban on speech that is inherently misleading; but may not do so on speech that is, at worst, only potentially misleading).

Under the third and fourth prongs of the Central Hudson test, the blanket ban also fails to pass constitutional muster. Under the third prong, the ban must be shown to directly advance the government’s interest. Presumably the government’s interest is not the protection of GlaxoSmithKline’s market but reduction of fraud in the market. If the latter, then a blanket ban does not directly advance the government’s interest. In construing the fit between means and ends, the Court has said that it has to be reasonable. Board of Trustees of State Univ. of N.Y., 492 U.S. 469, 476 (1989); Edenfield v. Fane, 507 U.S. 761 (1993). To be reasonable, the fit cannot be overbroad such that non-misleading speech is ensnared with inherently misleading speech, as would be the case here. Id. Thus, the means chosen does not directly advance the anti-fraud end and also renders the ban unconstitutional.

Under the fourth prong of the Central Hudson test, the ban cannot be more extensive than necessary to serve the government’s interest. Thompson v. W. States Med. Ctr., 535 U.S. 357 (2002). In that regard, if there are obvious, less speech restrictive alternatives, they must be used. Rubin v. Coors. Brewing Co., 514 U.S. 476, 491 (1995) (“The [Government’s] defects are further highlighted by the availability of alternatives that would prove less intrusive to the First Amendment’s protections for commercial speech”). The reliance on case by case enforcement against inherently misleading claims, currently the law, is an obvious, less speech restrictive alternative to the blanket ban advocated by GlaxoSmithKline. Moreover, in cases where the precise content of the speech harbors a potential to mislead that may be disabused through reliance on a disclaimer, it is the constitutional duty of the government to rely on a disclaimer in lieu of outright suppression. See Pearson v. Shalala, 164 F.3d 650, 657 (D.C. Cir. 1999); Whitaker v. Thompson, 353 F.3d 947, 953 (D.C. Cir. 2004)

For the foregoing reasons, the blanket ban advocated by SmithKline is prohibited because it results in the censorship of constitutionally protected speech.

GlaxoSmithKline’s Call for Unlawful Agency Action.

Under the Administrative Procedure Act, FDA is prohibited from engaging in an abuse of discretion. GlaxoSmithKline’s request that FDA use its power in complicity with that company to remove all claims from the market that would compete with its weight loss claims for Alli is inherently corrupt (reliance on government processes to achieve a private commercial restraint of trade) and, thus, invites an abuse of discretion. 5 U.S.C. § 706(2)(A); See also Davidson v. United States Dep’t of Energy, 838 F.2d 850 (6th Cir. 1988). The APA also prohibits the adoption of a legislative rule without notice and comment rulemaking. 5 U.S.C. § 553; See Sugar Cane Growers Cooperative v. Veneman, 289 F.3d 89 (D.C. Cir. 2002). In the first instance, in recognition that the rule it adopted defining allowable structure/function claims was legislative, FDA relied upon notice and comment rulemaking. See “Dietary Supplements; Comments on Report of the Commission on Dietary Supplement Labels” 63 Fed. Reg. 23633, 23625 (April 29, 1998). It thus made a preliminary determination that in acting in areas as sensitive as those concerning what information the public may receive (i.e., the health effects of nutrients), it cannot proceed by acting unilaterally but had to proceed through notice and comment rulemaking. Because the rules in question do determine the permissible scope of fundamental rights of all parties who speak in the food and dietary supplement markets, the rules are legislative and do require compliance with the familiar notice and comment requirements of the APA. 5 U.S.C. § 553; Sprint Corporation v. Federal Communications Comm’n, 315 F.3d 369 (D.C. Cir. 2003). GlaxoSmithKline’s demand that FDA proceed unilaterally is, thus, a call for unlawful agency action.

Conclusion.

For the foregoing reasons, the FDA should not act on GlaxoSmithKline’s petition except to deny it. The petition is borne of an undisclosed interest in securing from competition weight loss claims to the market advantage of GlaxoSmithKline’s Alli over-the-counter weight loss drug. If the FDA becomes complicit in that anti-competitive action, it will necessarily abuse its discretion in violation of the Administrative Procedure Act. The petition calls for an unconstitutional blanket speech ban. The petition calls for unilateral action in violation of the Administrative Procedure Act’s prohibition on legislative rulemaking without notice and comment.

Respectfully submitted,
Jonathan W. Emord
Andrea G. Ferrenz
Ryan Kelley
Counsel to Durk Pearson and Sandy Shaw

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